Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Siemens Medical Solutions USA, Inc., Ultrasound DI · Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

44 daysmedian FDA review time
106 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI2017-02-09790
K113179ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI2011-12-07400
K112596ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI2011-09-1690
K081148SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCERSiemens Medical Solutions USA, Inc., Ultrasound DI2008-12-222443
K082142ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI2008-11-131068
K081121MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI2008-06-04440
K080760ACUSON X300 ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI2008-04-25380
K072365SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI2007-10-17553
K072090SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMSSiemens Medical Solutions USA, Inc., Ultrasound DI2007-09-14460
K071036MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI2007-05-16340
K063803ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI2007-01-05149

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda